A Study of RO5028442 in Adult Male High-Functioning Autistic Patients
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01474278
First received: November 15, 2011
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
This multi-center, randomized, double-blind study will evaluate exploratory biomarkers and the safety and tolerability of a single dose of RO5028442 in adult male high-functioning autistic patients. In a cross-over design, patients will be randomized to receive either a single dose of RO5028442 or matching placebo with a washout period of 7-14 days. Anticipated time on study is up to approximately 9 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Autistic Disorder |
Drug: RO5028442 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | A Multi-centre, Randomized, Double-blind, Placebo-controlled, Two-period Cross-over, Exploratory Biomarker and Safety and Tolerability Study of a Single Dose of RO5028442 in Adult Male High-functioning Autistic Patients |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Efficacy: Behavior assessments [ Time Frame: up to 24 hours post-dose ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: up to 24 hours post-dose ] [ Designated as safety issue: No ]
| Enrollment: | 19 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: RO5028442
Single dose
|
| Placebo Comparator: 2 |
Drug: Placebo
Single dose
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with a diagnosis of Autistic Disorder as defined by DSM-IV, confirmed by the team and supported with the Autistic Diagnostic Observation Schedule (ADOS)
- Male adults, 18 to 45 years of age
- IQ > 70 (Wechsler Adult Intelligence Scale-Full scale)
- Body mass index (BMI) 18 to 35 kg/m2 inclusive
- Aberrant Behavior Checklist (ABC) - Irritability subscale score </= 13
Exclusion Criteria:
- Positive urine test for drugs of abuse
- Alcohol and/or substance abuse/dependence during the last 12 months
- Positive for hepatitis B, hepatitis C or HIV infection
- Clinically relevant cardiovascular, renal, hepatic or hematologic disease or disorder
- Active inflammatory pulmonary disease
- History of epilepsy/seizure disorder (except for simple febrile seizures)
- Initiation of new or major change in psychosocial intervention within 4 weeks prior to randomization
- Treatment with any investigational agent within 90 days prior to screening
- History of hypersensitivity or allergic reactions
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474278
Locations
| United States, California | |
| Los Ageles, California, United States, CA 90095 | |
| United States, Connecticut | |
| New Haven, Connecticut, United States, 06510 | |
| United States, New York | |
| Bronx, New York, United States, NY 10461 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01474278 History of Changes |
| Other Study ID Numbers: | BP27801 |
| Study First Received: | November 15, 2011 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013